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Gene Therapy to Improve Wound Healing in Patients With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00065663
Recruitment Status : Completed
First Posted : July 31, 2003
Last Update Posted : November 20, 2007
Information provided by:
Tissue Repair Company

Brief Summary:
Patients with diabetes may develop chronic wounds that respond poorly to treatment. Gene therapy with the platelet-derived growth factor-B gene has been shown to help with the healing of chronic wounds. This study will evaluate a new way to deliver the gene to the wound tissue.

Condition or disease Intervention/treatment Phase
Wounds and Injuries Diabetes Diabetic Foot Ulcers Foot Wounds Genetic: GAM501 Phase 1

Detailed Description:

Chronic wounds, such as diabetic ulcers, pressure ulcers, and venous stasis ulcers, cause significant morbidity in millions of patients each year in the United States. Individuals with long-standing diabetes develop both peripheral vascular disease and peripheral neuropathy. These patients may not feel pressure from shoes or objects which can damage their skin. Once a wound is formed, it may heal very slowly or not at all due to diabetic complications.

Platelet-derived growth factor-B (PDGF-B) has been approved for use in diabetic ulcers. However, delivery and maintenance of the drug at the wound site in sufficient quantities for a sufficient period of time is a major hurdle to widespread use.

Gene activated matrix (GAM) technology offers the opportunity to place a therapeutic gene contained within a structural matrix into a wound site. This study will evaluate the safety and potential clinical utility of topical applications of GAM501, a gene for PDGF-B contained within an E1-deleted adenoviral vector and formulated in a bovine type I collagen gel. This formulation allows for the migration of wound repair cells into the structural matrix, where they encounter the viral vector and subsequently produce the therapeutic protein within the local wound environment.

Participants in this study will receive up to four treatments with GAM501. Participants will be followed by multiple observations over a 6 to 7 month period.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Growth Factor Gene Therapy for Wound Healing
Study Start Date : August 2002
Estimated Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Adequately controlled diabetes mellitus (type I or II) as defined by HbA1c < 10.0%
  • Cutaneous, lower extremity, plantar medial or lateral surface ulcer between 1 and 10 cm2 post-debridement
  • Ulcer present for > 6 weeks prior to study entry
  • Ulcer free of all necrotic and infected soft tissue
  • Affected limb transcutaneous oxygen pressure (TcpO2) > 30 mmHg at screening or a palpable dorsal pedal or posterior tibial pulse
  • Inability to perceive 10 grams pressure using a Semmes-Weinstein 5.07 monofilament in the peri-ulcer area

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065663

United States, Arizona
Foot and Ankle Medical Center
Phoenix, Arizona, United States, 85015
United States, California
University of California, San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
Tissue Repair Company
Study Director: Barbara Sosnowski, PhD Tissue Repair Company

ClinicalTrials.gov Identifier: NCT00065663     History of Changes
Other Study ID Numbers: NIAMS-093
R44AR046154 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2003    Key Record Dates
Last Update Posted: November 20, 2007
Last Verified: November 2007

Keywords provided by Tissue Repair Company:
gene transfer
platelet-derived growth factor-B
diabetic ulcer

Additional relevant MeSH terms:
Wounds and Injuries
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases